Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - prometax

Document Subject

Generated Narrative: MedicinalProductDefinition mp78ea274f37edfa196d1a7ba45e31f4e3

identifier: http://ema.europa.eu/identifier/EU/1/98/092/001-3

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Prometax 1.5 mg hard capsules

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-78ea274f37edfa196d1a7ba45e31f4e3

identifier: http://ema.europa.eu/identifier/EU/1/98/092/001-3

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - prometax

Attesters

What is in this leaflet

1. What Prometax is and what it is used for
2. What you need to know before you take Prometax
3. How to take Prometax
4. Possible side effects
5. How to store Prometax
6. Contents of the pack and other information

The active substance of Prometax is rivastigmine.

Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer s dementia or dementia due to Parkinson s disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer s disease and dementia associated with Parkinson s disease.

Prometax is used for the treatment of adult patients with mild to moderately severe Alzheimer s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour. The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson s disease.

Do not take Prometax

• if you are allergic to rivastigmine (the active substance in Prometax) or any of the other ingredients of this medicine (listed in section 6).
• if you have a skin reaction spreading beyond the patch size, if there is a more intense local reaction (such as blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch. If this applies to you, tell your doctor and do not take Prometax.

Warnings and precautions Talk to your doctor before taking Prometax:

• if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
• if you have, or have ever had, an active stomach ulcer.
• if you have, or have ever had, difficulties in passing urine.
• if you have, or have ever had, seizures.
• if you have, or have ever had, asthma or severe respiratory disease.
• if you have, or have ever had impaired kidney function.
• if you have, or have ever had, impaired liver function.
• if you suffer from trembling.
• if you have a low body weight.
• if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged. If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.

If you have not taken Prometax for more than three days, do not take the next dose until you have talked to your doctor.

Children and adolescents There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer s disease.

Other medicines and Prometax Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Prometax should not be given at the same time as other medicines with similar effects to Prometax. Prometax might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson s disease or to prevent travel sickness).

Prometax should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands.

If you have to undergo surgery whilst taking Prometax, tell your doctor before you are given any anaesthetics, because Prometax may exaggerate the effects of some muscle relaxants during anaesthesia.

Caution when Prometax is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.

Caution when Prometax is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, the benefits of using Prometax must be assessed against the possible effects on your unborn child. Prometax should not be used during pregnancy unless clearly necessary.

You should not breast-feed during treatment with Prometax.

Driving and using machines Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. Prometax may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.

Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How to start treatment Your doctor will tell you what dose of Prometax to take.

• Treatment usually starts with a low dose.
• Your doctor will slowly increase your dose depending on how you respond to treatment.
• The highest dose that should be taken is 6.0 mg twice a day.

Your doctor will regularly check if the medicine is working for you. Your doctor will also monitor your weight whilst you are taking this medicine.

If you have not taken Prometax for more than three days, do not take the next dose until you have talked to your doctor.

Taking this medicine

• Tell your caregiver that you are taking Prometax.
• To benefit from your medicine, take it every day.
• Take Prometax twice a day, in the morning and evening, with food.
• Swallow the capsules whole with a drink.
• Do not open or crush the capsules.

If you take more Prometax than you should If you accidentally take more Prometax than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Prometax have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and fainting may also occur.

If you forget to take Prometax If you find you have forgotten to take your dose of Prometax, wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may have side effects more often when you start your medicine or when your dose is increased. Usually, the side effects will slowly go away as your body gets used to the medicine.

Very common (may affect more than 1 in 10 people)

• Feeling dizzy
• Loss of appetite
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea

Common (may affect up to 1 in 10 people)

• Anxiety
• Sweating
• Headache
• Heartburn
• Weight loss
• Stomach pain
• Feeling agitated
• Feeling tired or weak
• Generally feeling unwell
• Trembling or feeling confused
• Decreased appetite
• Nightmares

Uncommon (may affect up to 1 in 100 people)

• Depression
• Difficulty in sleeping
• Fainting or accidentally falling
• Changes in how well your liver is working

Rare (may affect up to 1 in 1,000 people)

• Chest pain
• Rash, itching
• Fits (seizures)
• Ulcers in your stomach or intestine

Very rare (may affect up to 1 in 10,000 people)

• High blood pressure
• Urinary tract infection
• Seeing things that are not there (hallucinations)
• Problems with your heartbeat such as fast or slow heartbeat
• Bleeding in the gut shows as blood in stools or when being sick
• Inflammation of the pancreas the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
• The signs of Parkinson s disease get worse or getting similar signs such as stiff muscles, difficulty in carrying out movements

Not known (frequency cannot be estimated from the available data)

• Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)
• Dehydration (losing too much fluid)
• Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)
• Aggression, feeling restless
• Uneven heartbeat

Patients with dementia and Parkinson s disease These patients have some side effects more often. They also have some additional side effects:

Very common (may affect more than 1 in 10 people)

• Trembling
• Fainting
• Accidentally falling

Common (may affect up to 1 in 10 people)

• Anxiety
• Feeling restless
• Slow and fast heartbeat
• Difficulty in sleeping
• Too much saliva and dehydration
• Unusually slow movements or movements you cannot control
• The signs of Parkinson s disease get worse or getting similar signs such as stiff muscles, difficulty in carrying out movements and muscle weakness

Uncommon (may affect up to 1 in 100 people)

• Uneven heartbeat and poor control of movements

Other side effects seen with Prometax transdermal patches and which may occur with the hard capsules:

Common (may affect up to 1 in 10 people)

• Fever
• Severe confusion
• Urinary incontinence (inability to retain adequate urine)

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity (high level of activity, restlessness)

Not known (frequency cannot be estimated from the available data)

• Allergic reaction where the patch was used, such as blisters or skin inflammation If you get any of these side effects, contact your doctor as you may need medical assistance.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 30 C.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Prometax contains

• The active substance is rivastigmine hydrogen tartrate.
• The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171) and shellac.

Each Prometax 1.5 mg capsule contains 1.5 mg of rivastigmine. Each Prometax 3.0 mg capsule contains 3.0 mg of rivastigmine. Each Prometax 4.5 mg capsule contains 4.5 mg of rivastigmine. Each Prometax 6.0 mg capsule contains 6.0 mg of rivastigmine.

What Prometax looks like and contents of the pack

• Prometax 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint ENA 713 1,5 mg on the body.
• Prometax 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint ENA 713 3 mg on the body.
• Prometax 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint ENA 713 4,5 mg on the body.
• Prometax 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint ENA 713 6 mg on the body. They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) but these may not all be available in your country.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Novartis Farmac utica, S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain

Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma GmbH T l/Tel: +49 911 273 0

esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Sandoz Polska Sp. z o.o. Tel.: +48 22 549 1France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Laborat rio Normal - Produtos Farmac uticos, Lda. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu Package leaflet: Information for the user

Prometax 2 mg/ml oral solution rivastigmine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.